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Given Imaging SmartPill GI Monitoring System User Manual

Measures whole gut and regional gut transit times. measurements are used for evaluating motility disorders.
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Appendix: Electrical Safety
SmartPill® GI Monitoring
System
User Manual
MotiliGI® v3.0
Doc: 111482-01
March 2013

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Summary of Contents for Given Imaging SmartPill GI Monitoring System

  • Page 1 Appendix: Electrical Safety SmartPill® GI Monitoring System User Manual MotiliGI® v3.0 Doc: 111482-01 March 2013...
  • Page 2 Appendix: Electrical Safety Copyrights Text, graphics, logos and images in this manual are the property of Given Imaging and protected by United States and international copyright laws. This Manual may not be transferred or reproduced in any form without the written permission of Given Imaging.
  • Page 3 The Limited Warranty does not cover software or damages due to misuse, neglect, alteration, repair, improper installation, set-up, calibration or improper testing. Given Imaging is not liable for any incidental or consequential loss, damage, or expense arising, directly or indirectly, from the use of the system or capsule.

  • Page 4: Table Of Contents

    Appendix: Electrical Safety Table of Contents ............................. 1 Introduction and Components ....................9 Using this Manual ......................... 9 System Components ......................10 SmartPill Capsule Pack ....................10 Capsule Operational Specifications ................10 SmartBar ........................... 10 Data Receiver ........................11 Docking Station ....................... 12 Activation Fixture ......................
  • Page 5 Appendix: Electrical Safety Setting up the Computer ....................23 Preparing for a Test ....................... 25 Before the Test Day ......................25 Charging the Data Receiver ................... 25 Preparing the Patient ...................... 26 During the Office Visit ....................27 Starting a Test ......................... 30 Preparing the System ......................
  • Page 6 Appendix: Electrical Safety Gastric Acidity ......................... 52 Procedure Deviation – Additional Meal Before 6 Hours .......... 53 Select Gastric Emptying ....................55 Magnitude of pH Rise at Emptying ................56 Gastric Pressure Characteristics ..................57 Small Bowel pH profile ....................57 Small Bowel Pressure Characteristics ................
  • Page 7 Appendix: Electrical Safety MotiliGI Features........................83 MotiliGI User Interface ..................... 83 Titlebar ..........................83 Main Menus ........................83 Toolbar Icons ........................83 Graph Area ........................85 Data Panels ........................85 Time Slider Control ......................85 Display Tabs ........................85 Status Bar ......................... 85 MotiliGI Keyboard Shortcuts ..................
  • Page 8 Installing Software ......................108 MotiliGI Administrator ....................108 Installing Software from a CD ..................109 Installing Software from a File on the System Computer Hard Drive ....109 Uninstalling MotiliGI ....................110 Installing MotiliGI ......................110 Appendix: Electrical Safety ....................112 Index ...........................116 Contacting Given Imaging ....................119...

  • Page 9: Introduction And Components

    Appendix: Electrical Safety Using this Manual Complete user training and read this manual before running the SmartPill System. This manual contains important safety information and contraindications. This manual makes use of 2 special notations: Warning and Caution, the meanings of which are: Warning Potentially hazardous situations which could result in serious adverse reactions (death or serious injury) or...

  • Page 10: System Components

    Appendix: Electrical Safety System Components SmartPill Capsule Pack Each capsule pack contains a single-use capsule, calibration buffer, instructions for use and a patient diary. The capsule measures pressure, pH, and temperature to determine transit times of the stomach, small bowel, and colon. Transit times derived by capsule motility procedures provide alternatives to other tests such as gastric emptying scintigraphy, whole gut scintigraphy, and radio-opaque markers.

  • Page 11: Data Receiver

    Appendix: Electrical Safety Data Receiver The data receiver records biomedical data sent by the capsule. It is worn by the patient on a belt clip or a lanyard (around the neck). The data receiver features an Event button that when pushed places a marker in the electronic data. A patient diary for recording the time and reason for the event button use is stored on the backside of the receiver.

  • Page 12: Docking Station

    Appendix: Electrical Safety Docking Station The docking station establishes electronic communication between the data receiver and the system computer for data download and serves as a charging stand for the data receiver. The docking station weighs approximately 200 grams (0.45 lbs). Caution Use only the Power Supply (REF 30100900) supplied with the SmartPill Docking Station.

  • Page 13: Activation Fixture

    Appendix: Electrical Safety LED Color State Action Recommended Charging Continue charging until the LED turns green. Yellow A charging circuit fault has Undock and then re-dock the data receiver in the occurred docking station. If the yellow light persists contact technical support. Green Fully charged The data receiver is ready for use.

  • Page 14: Accessories

    Caution Use MotiliGI only on the system computer supplied with the SmartPill GI Monitoring System. Installing and operating MotiliGI on another computer is not recommended or supported by SmartPill Corporation.
  • Page 15 Appendix: Electrical Safety Warning Do not connect items to the SmartPill GI Monitoring System that are not part of the system.

  • Page 16: Use And Care Of The System

    WGTT Whole gut transit time Intended Use/Indications for Use The SmartPill GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal (GI) tract transit times are used for evaluating motility disorders.

  • Page 17: Restricted Use

    Significant data dropout can occur in severely obese patients (>40 BMI). Restricted Use Caution The SmartPill GI Monitoring System equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. Not for use with oxygen or oxygen-enriched atmospheres.

  • Page 18: Recycling And Disposal Instructions

    Appendix: Electrical Safety rechargeable batteries Recycling and Disposal Instructions Recycle the data receiver and docking station following the local, regional, and national regulations for electronic devices. The capsule contains silver oxide batteries. Recycle unused capsules following the local, regional and national regulations for electronic devices. Dispose of used capsules following local, regional and national regulations for disposing of human excrement.

  • Page 19: Data Receiver Display Messages

    Appendix: Electrical Safety Type BF equipment CE marking and notified body number 0123 Authorized representative Sufficient for one test IP57 Ingress protection rating Serial number Fragile Keep dry Data Receiver Display Messages Looking for capsule—appears during test initiation before the receiver receives the first data packet from the capsule. Locked onto capsule—appears after the data receiver receives first data packet from the capsule.

  • Page 20: Risks And Safety

    Appendix: Electrical Safety The receiver’s battery life. 1 bar = 1 day of battery life. 3 bars = 3+ days. Risks and Safety Warning This device does not differentiate between slow motility and functional outlet obstruction. Non-Passage Risks associated with capsule ingestion and transit are minimal. The primary hazard is capsule retention.

  • Page 21: Patient-Contacting Materials

    Appendix: Electrical Safety was one additional esophageal retention, eight gastric retentions, four small bowel retentions and five colonic retentions. These resolved either without intervention or with endoscopy/colonoscopy. Patient-Contacting Materials Patient-contacting materials include polyurethane, a polyurethane-polycarbonate blend, Teflon coated with polyhema, an ISFET pH sensor, epoxy and UV-cured adhesive. All patient contacting materials have been tested for biocompatibility and have been found non-toxic, non-sensitizing, and non-irritating.

  • Page 22: Docking Station

    Appendix: Electrical Safety Caution Do not attempt to replace batteries in the data receiver. Docking Station 1. Unplug docking station from the power supply. 2. Dust the surfaces of the docking station with a soft, dry cloth. Do not use water or liquids.

  • Page 23: Setting-Up The System

    Appendix: Electrical Safety Getting Started 1. Remove the data receiver, docking station, activation fixture, USB cable, power adapter, and power cord from the starter kit case. 2. Unpack the system computer and power supply from its shipping container. Connect the computer to a source of AC power. ►...
  • Page 24 Appendix: Electrical Safety 4. Click OK. You will be asked to confirm the clinic identification number you entered; click Yes to proceed to the First Login Sequence screen. 5. Click OK. The administrator user login screen appears. 6. Create a username and password for the administrator account for MotiliGI. The username and password must contain a minimum of 5 alphanumeric characters.

  • Page 25: Preparing For A Test

    Appendix: Electrical Safety Before the Test Day Fully charge the data receiver the day or night before starting a test. Charging can take up to 5 hours. Charging the Data Receiver 1. Ensure that the data receiver is off. If any characters appear on the display, turn off the data receiver by simultaneously pressing the 2 buttons on the front of the unit for approximately 5 seconds.

  • Page 26: Preparing The Patient

    Appendix: Electrical Safety Preparing the Patient Before the Office Visit 1. Review these requirements and restrictions with the patient. The test requires fasting for accurate results. Schedule Restriction 24 hours before the test Do not consume alcohol. 8 hours before the start of the test Do not eat or drink.

  • Page 27: During The Office Visit

    Appendix: Electrical Safety Rolaids Insulin-dependent diabetic patients must take half of their normal morning dose of insulin and monitor glucose levels according to normal routines. 3. Review SmartBar ingredients and rule out any food allergies. The SmartBar contains a small amount of gluten. The SmartBar does not contain lactose.
  • Page 28 Appendix: Electrical Safety Do not use tobacco. During the entire test Do not consume alcohol. If you are diabetic, monitor glucose levels and follow your personal treatment plan. If you are unsure, contact the doctor who manages your diabetes. Avoid vigorous exercise such as sit-ups, abdominal crunches, and prolonged aerobic activity (greater than 15 minutes).
  • Page 29 Appendix: Electrical Safety Patients may resume a normal diet 6 hours after swallowing the capsule. Except for restrictions noted on the Patient Instructions Sheets, patients may resume normal activities when released from your office. Warning Magnetic Resonance Imaging (MRI) must not be performed on a patient who has ingested the capsule until capsule passage is confirmed by the physician’s review of the MotiliGI graph or abdominal x-ray.

  • Page 30: Starting A Test

    Appendix: Electrical Safety Preparing the System Perform these steps immediately before or after a patient’s arrival at the office. 1. Turn on the system computer. 2. Open MotiliGI: Click on the desktop. Select Start > All Programs > SmartPill > MotiliGI. 3.

  • Page 31: Step 2: Enter Patient Information

    Appendix: Electrical Safety Replace the data receiver with a fully charged receiver. Allow additional charging time for the current receiver. The data receiver must be turned off during charging. Charging the data receiver while turned on results in a partial charge. You may lose test data. 2.
  • Page 32 Appendix: Electrical Safety Depending on your selections, other screens may appear. For example, an override screen for a contraindication or caution may appear. (Optional) Enter notes and click Physician Ok. (Optional) Click End Test. 3. Proceed to the optional tabs below or click Next >. Optional Tabs: Prior GI Procedures, Allergies and Medications, Symptoms Entering information in these tabs is optional.

  • Page 33: Creating Templates

    Appendix: Electrical Safety Creating Templates: To save time you can create text descriptions that are saved in MotiliGI. These text templates can be reused from patient to patient. Text descriptions saved this way are called templates. We recommend creating general templates with blank lines to indicate where patient specific information can be inserted.

  • Page 34: Step 3: Assemble Materials

    Appendix: Electrical Safety The templates remains in the Template list. To delete the selection, click Delete Template. Step 3: Assemble Materials 1. Follow the prompts. The capsule’s instructions for use are in the inside pocket of the capsule pack. 2. Click Next >.

  • Page 35: Step 4: Activate Capsule

    Appendix: Electrical Safety Step 4: Activate Capsule 1. Follow the prompts. Figure 4 - Capsule Activation Window Caution Once the capsule is activated, keep the capsule at least one (1) foot away from the activation fixture. If the capsule is kept near the activation fixture, stray magnetic fields from the activation fixture may deactivate the capsule.

  • Page 36: Step 5: Select Capsule

    Appendix: Electrical Safety The data receiver’s display then indicates the capsule’s data: Capsule Serial SS = signal strength number P = pressure The capsule’s data was received. / [X] = The data was not received. icon appears in the lower-right corner of MotiliGI: . If the capsule did not activate, repeat the procedure.
  • Page 37 Appendix: Electrical Safety 1. To select the capsule you activated, click the row that matches the capsule container’s serial number. An arrow indicates your selection. If the software does not detect the capsule within a minute, observe the data receiver’s display to confirm the capsule is active. If the capsule is activated the data receiver displays this data during a test.

  • Page 38: Step 6: Enter Pressure Calibration Code

    Appendix: Electrical Safety Step 6: Enter Pressure Calibration Code 1. Locate the calibration code found on the lid of the capsule container. Enter the code. 2. Click Next >. Step 7: Add pH Calibration Buffer Caution Once exposed to buffer, the capsule must be ingested within 2 hours or discarded. Confirm that the patient is available and prepared to proceed with the test before you begin Step 7.

  • Page 39: Step 8: Capsule Ph Calibration

    Appendix: Electrical Safety Caution The orientation of the capsule in the capsule container is important. When reinserting the capsule, ensure the pH sensor is in the same orientation relative to the diamond-shaped window of the capsule container. Figure 5 - Capsule Orientation A –...

  • Page 40: Step 9: Ingestion

    Appendix: Electrical Safety Calibration normally takes less than 3 minutes, but may take up to 15 minutes. During calibration, it is normal for fluctuations in the pH value to occur. Calibration is complete when all these signals appear: The pH value stabilizes at 6.0. The “pH Calibration Complete”...
  • Page 41 Appendix: Electrical Safety Caution To avoid loss of data during Step 9.2, avoid separating the capsule and data receiver by more than 5 feet. The data receiver records biomedical data from within the patient’s GI tract. Every few seconds, the pH and pressure readings update on the data receiver’s display. Dispose of the pH calibration buffer following all applicable regulations.

  • Page 42: Step 10: Complete Discharge Checklist

    Appendix: Electrical Safety Step 10: Complete Discharge Checklist 1. Review the discharge checklist with the patient. Instruct the patient to wait 3 minutes in the bathroom before flushing the toilet after each bowel movement. Explain that to confirm body exit, the patient must let the capsule communicate with the data receiver after bowel movements.

  • Page 43: Live Monitoring Mode (Optional)

    Appendix: Electrical Safety Guidelines: Indication for Use Return Data Receiver After Measuring GET 24-48 hours Measuring WGTT 2–5 days 4. Check the box I have completed the patient’s discharge. 5. Click Finish. The Patient Information screen appears. 6. Do any of the following: Enter notes regarding the patient’s capsule ingestion.

  • Page 44: Aborting A Test - Deactivating The Capsule

    Appendix: Electrical Safety Aborting a Test Deactivating the Capsule Caution If a test is aborted before the capsule has been exposed to buffer solution, the capsule may be deactivated but must be used within two (2) hours or discarded. Caution If a test is aborted before ingestion and the capsule has not been exposed to buffer solution, the capsule may be deactivated but must be used within one month or before its expiration date is reached, whichever is sooner.

  • Page 45: Ending A Test

    Appendix: Electrical Safety To determine capsule exit, you can observe the data display on the data receiver for at least 2 minutes. If the data receiver is receiving data from the capsule, this icon appears every 20–40 seconds, which confirms that the capsule is still in the patient. No evidence of the icon within the 2-minute observation is presumptive evidence of capsule exit.

  • Page 46: Post Test Notes

    Appendix: Electrical Safety Select Action > Download Data. Click the toolbar icon. The Patient Information screen opens. Post Test Notes 7. In the Procedure Notes tab, click in the post-test notes field to enter notes elicited from the patient which were captured when the patient returned the data receiver. See Adding and Creating a Template.

  • Page 47: Confirming Capsule Exit

    Appendix: Electrical Safety Confirming Capsule Exit Caution Physicians should confirm capsule exit. Monitor patients until capsule passage is confirmed. 1. Use one of these methods: Ask the patient whether the capsule was observed in his or her stool. Download the test. Analyze the MotiliGI graph for evidence of exit: an abrupt drop in temperature or loss of signal that coincides with a diary entry for a bowel movement.

  • Page 48: Introduction To The Test Analysis Wizard

    Appendix: Electrical Safety The MotiliGI software identifies capsule ingestion, gastric emptying, ICJ, body exit, and computes GET, SBTT, CTT, SLBTT, WGTT, and motility indices. You can: Match events with patient diary entries. Analyze test to mark capsule ingestion, gastric emptying, ICJ and body exit. Compare the markers you defined with markers identified by the MotiliGI software.
  • Page 49 Appendix: Electrical Safety Figure 6 - Test Analysis Wizard...

  • Page 50: Analyzing The Test

    Appendix: Electrical Safety Navigates to any step of the wizard that you have completed Yellow light: You must take action to complete this step. Green light: You have completed this step. To take an action, click a link. You can enter notes. Analyzing the Test Patient Diary Events The graph displays each event in succession.

  • Page 51: Select Capsule Ingestion

    Appendix: Electrical Safety Hide the event by uncheck the box Show the Event on the Graph. You can edit this information at any time by using the Point Annotation Viewer or the Annotation Viewer: 2. Click Next >. Select Capsule Ingestion Term Definition Ingestion...

  • Page 52: Gastric Acidity

    Appendix: Electrical Safety 2. Move the cursor over the graph and click on the location where you believe ingestion occurred. 3. Click Next >. Gastric Acidity A stomach baseline pH below 4 indicates normal acidic conditions. Baselines above 4 may indicate ineffective gastric acid production, buffering due to meals, or medications that suppress gastric acid.

  • Page 53: Procedure Deviation Additional Meal Before 6 Hours

    Appendix: Electrical Safety Procedure Deviation Additional Meal Before 6 Hours Snacks or meals may be recorded in the diary. A rise in pH and drop in temperature may indicate a meal response in the stomach. In figure above there is no evidence of an additional meal prior to capsule gastric emptying.
  • Page 54 Appendix: Electrical Safety Figure 7 - Eating a meal In the figure above, the patient ingested a liquid meal (Ensure) at 6 hours after capsule ingestion and ate dinner approximately 8 hours after capsule ingestion. The ingestion of food (Ensure and dinner) caused an abrupt rise in pH (B) and a decrease in temperature (A).

  • Page 55: Select Gastric Emptying

    Appendix: Electrical Safety Select Gastric Emptying Use GET to evaluate the patient’s gastric emptying function. Generally, an abrupt increase of 3 or more pH units occurs as the capsule exits the stomach and enters the duodenum. Term Definition Gastric emptying The beginning of the first increase in pH that results in a sustained pH rise.

  • Page 56: Magnitude Of Ph Rise At Emptying

    Appendix: Electrical Safety Magnitude of pH Rise at Emptying Term Definition Duodenal pH baseline Determined by observing the pH within the first 30 minutes after gastric emptying. Sustained pH increase No transient pH drops occur for greater than 10 minutes. Click Next >.

  • Page 57: Gastric Pressure Characteristics

    Appendix: Electrical Safety Gastric Pressure Characteristics The relevance of SmartPill pressure patterns in the stomach to pressure patterns obtained using manometry is unknown. Click Next >. ► Small Bowel pH profile 1. Determine whether you observe a gradually rising pH profile characteristic of the small bowel.

  • Page 58: Small Bowel Pressure Characteristics

    Appendix: Electrical Safety 2. Click Next >. Small Bowel Pressure Characteristics The clinical significance of SmartPill pressure patterns in the small bowel is unknown. Click Next >. ►...

  • Page 59: Select Ileo-Cecal Junction

    Appendix: Electrical Safety Select Ileo-Cecal Junction The standard small bowel pH profile shows a gradual pH rise usually followed by a plateau of the pH pattern. Transient pH drops may interrupt this profile but returns to their previous level within 10 minutes. The pH drop associated with the capsule passing through the ICJ occurs after the gradual sustained increase in pH through the small bowel.

  • Page 60: Colonic Pressure Characteristics

    Appendix: Electrical Safety Colonic Pressure Characteristics The relevance of SmartPill pressure patterns in the colon to colonic pressure patterns obtained using manometry is unknown. Click Next >. ►...

  • Page 61: Warning: Data Collected During Capsule Low Voltage

    Appendix: Electrical Safety Warning: Data Collected During Capsule Low Voltage If the MotiliGI software detects a low voltage condition in the capsule, a warning appears. Caution When a low voltage warning is present, body exit confirmation cannot be determined solely by temperature drop.

  • Page 62: Select Body Exit

    Appendix: Electrical Safety Select Body Exit Term Definition Body exit The time of the last temperature reading at body temperature, coinciding with an abrupt loss of capsule data. The time of the last abrupt rise in pressure. An abrupt loss of signal from the capsule does not reliably indicate body exit. You must corroborate (to within 30 minutes) body exit with a recorded bowel movement in the patient diary.
  • Page 63 Appendix: Electrical Safety Figure 8 - Body Exit The figure above provides an optimal representation of body exit including a bowel movement event marker on the graph and in the patient diary temperature drop (A), a decrease in temperature (B) and an abrupt loss of data (C). Caution If the diary does not contain a bowel movement entry concomitant with a temperature drop and/or loss of pressure and pH signal, the patient should be monitored for symptoms of bowel obstruction.

  • Page 64: Review Your Physiological Markers With Motiligi's Markers

    Appendix: Electrical Safety Review Your Physiological Markers with MotiliGI Term Description Computed markers Dashed vertical line on the graph, labeled “computed.” Your markers Solid vertical lines. Equivalent Your marker and the computed marker are within 5 minutes of each other, labeled “equivalent.” The computed time is grayed out. Click Next >.

  • Page 65: Motiligi-Computed Capsule Ingestion

    Appendix: Electrical Safety MotiliGI-Computed Capsule Ingestion MotiliGI determines ingestion by finding the point at which temperature stabilized at body temperature. 1. Follow the prompts. 2. Click Next >.

  • Page 66: Motiligi-Computed Gastric Emptying

    Appendix: Electrical Safety MotiliGI-Computed Gastric Emptying MotiliGI selects gastric emptying by finding the beginning of the abrupt, sustained pH rise. Medications, therapies, and diseases that alter gastric or small bowel pH may influence the accuracy of computed gastric emptying. 1. Follow the prompts. 2.

  • Page 67: Absence Of Gastric Emptying

    Appendix: Electrical Safety Absence of Gastric Emptying If you did not identify gastric emptying, the wizard reminds you of the omission and asks you to select gastric emptying. To review the MotiliGI computed gastric emptying, click <Back. Caution If gastric emptying is not observed, body exit should be confirmed by analysis of data. If body exit cannot be confirmed, the patient should be monitored for symptoms of bowel obstruction.

  • Page 68: Gastric Emptying Statistics

    Appendix: Electrical Safety Gastric Emptying Statistics This step allows you to enter observations about the gastric emptying statistics. Click Next >. ►...

  • Page 69: Gastric Emptying Time Evaluation

    Appendix: Electrical Safety Gastric Emptying Time Evaluation Use GET to evaluate the patient’s gastric emptying function. Term Definition Premature gastric emptying Within 30 minutes of ingestion. Normal gastric emptying After 2 hours but before 4 hours of ingestion. Delayed gastric emptying After 4 hours of ingestion.

  • Page 70: Motiligi-Computed Icj

    Appendix: Electrical Safety MotiliGI-Computed ICJ MotiliGI selects ICJ by looking for the first and largest pH drop between 30 minutes and 6 hours after gastric emptying. 1. Follow the prompts. 2. Click Next >.

  • Page 71: Small Bowel Transit Time Evaluation

    Appendix: Electrical Safety Small Bowel Transit Time Evaluation The clinical significance of SmartPill’s transit time in the small bowel is unknown. Click Next >. ►...

  • Page 72: Motiligi-Computed Body Exit

    Appendix: Electrical Safety MotiliGI-Computed Body Exit MotiliGI selects body exit based on temperature and pressure. An abrupt loss of signal from the capsule does not reliably indicate body exit. You must corroborate (to within 30 minutes) body exit with a recorded bowel movement in the patient diary. Caution If the diary does not contain a bowel movement entry concomitant with a temperature drop and/or loss of pressure\pH signal, the patient should be monitored for symptoms of bowel obstruction.

  • Page 73: Absence Of Body Exit

    Appendix: Electrical Safety Absence of Body Exit If you did not identify body exit, this step appears. To review the computed body exit, click <Back. Caution If the diary does not contain a bowel movement entry concomitant with a temperature drop and/or loss of pressure and pH signal, the patient should be monitored for symptoms of bowel obstruction.

  • Page 74: Colonic Transit Time Evaluation

    Appendix: Electrical Safety Colonic Transit Time Evaluation MotiliGI uses your interpretation of ICJ (colonic entry) and body exit events to compute the CTT. Click Next >. ► Test Analysis Review The analysis is complete.

  • Page 75: Reading Test Summary Reports

    Appendix: Electrical Safety Click Finish. ► Reading Test Summary Reports When the test analysis wizard is complete, a summary report of results and descriptive data appears. These reports summarize test data, statistics, and observations, and help evaluate delayed gastric emptying, constipation and gastrointestinal motility. You can display the test summary reports any time: Click the toolbar icon.

  • Page 76: Transit Data Tab

    Appendix: Electrical Safety Transit Data Tab This tab lets you compare your transit time data to the computed data. If one or more endpoint markers are not defined, n/a (not applicable) appears for the transit time value. Combined small and large bowel transit time (SLBTT) can be used as a surrogate measure for CTT when CTT cannot be determined.

  • Page 77: Descriptive Data Tab

    Appendix: Electrical Safety Descriptive Data Tab This tab summarizes calculated pressure and pH data points. The clinical significance of these pressure and pH descriptive statistics is unknown.

  • Page 78: Interpretations Tab

    Appendix: Electrical Safety Interpretations Tab This tab displays notes made during analysis and provides a text section for capturing post-test observations, conclusions and recommendations. The information entered in this tab becomes part of the patient’s record. Alternatively, you can enter interpretations through the Interpretations tab of the Patient Information screen.

  • Page 79: Properties Tab

    Appendix: Electrical Safety Properties Tab This tab displays information about the equipment used for the test. Examples of Physiological Markers Ingestion The ingestion landmark starts the test and is the beginning of GET. MotiliGI determines the ingestion landmark by finding the point just before temperature stabilizes to body temperature, as illustrated below.

  • Page 80: Gastric Emptying

    Appendix: Electrical Safety Figure 9 - Ingestion Gastric Emptying Gastric emptying marks the end of GET and the start of SBTT as shown below. Figure 10 - Gastric Emptying MotiliGI looks for an abrupt increase of 3 or more pH unit as the capsule exits the stomach and enters the duodenum.

  • Page 81: Icj

    Appendix: Electrical Safety Factors that may influence gastric emptying include: Medications, therapies, and diseases that alter gastric or small bowel pH. ICJ is usually found between 2 to 6 hours after gastric emptying, as seen below. ICJ marks the transition of the capsule from the small bowel into the colon. ICJ marks the end of SBTT and the start of CTT.
  • Page 82 Appendix: Electrical Safety Figure 12 - Body Exit...

  • Page 83: Motiligi Features

    Appendix: Electrical Safety MotiliGI User Interface The MotiliGI user interface consists of main dropdown menus, toolbar, graph area, control panels, time slider control and status bar. Figure 13 - MotiliGI User Interface Titlebar Labeled A on Figure 13. The titlebar displays the filename constructed from the Patient ID and the time and date of the beginning of the test, for example Patient ID #207516, 9:29:44 AM, 28 March, 2007.
  • Page 84 Appendix: Electrical Safety Open – Open a test. You can choose to open by patient name or filename. Live Monitoring Download Data Analyze Test Print Print Preview Generate Report Test Summary Patient Info Annotation Viewer Display Ingestion Display Stomach Display Gastric Emptying Display Small/Large Bowel Display Body Exit Display Entire Test...

  • Page 85: Graph Area

    Appendix: Electrical Safety Set Gastric Emptying Marker Set ICJ Marker Set Body Exit Marker Graph Area Labeled D on Figure 13. The graph area presents plots of pressure, pH, and temperature data captured throughout the test, and point and range annotations. The left Y-axis is the pressure scale, the right Y-axes are pH and temperature scales, and the X-axis is the elapsed time of the test.

  • Page 86: Motiligi Keyboard Shortcuts

    Appendix: Electrical Safety Data Receiver Status Icons Icon Description Disconnected – No USB connection exists between MotiliGI and the data receiver. Connected – MotiliGI is communicating with the data receiver. Test Status Icons Icon Description Capsule Not Found – MotiliGI is not receiving data from a capsule and indicates a capsule has not been activated or the capsule is out of range of the data receiver.

  • Page 87: Opening A Test By The File Name

    Appendix: Electrical Safety To show all tests in the Results box, click Show All Tests. To reduce the size of the list, enter all or part of the patient’s name or patient ID. You can also enter a test date or range of dates in the “Find by test date” box. 3.

  • Page 88: Exiting Motiligi

    Appendix: Electrical Safety Exiting MotiliGI MotiliGI saves changes to the test when you exit. To exit MotiliGI, either: Select File > Exit Close using the in the upper right hand corner. Caution Do not close MotiliGI while operating the Test Initiation Wizard because data can be lost. Complete or abort the Wizard first.

  • Page 89: Graph Tab

    Appendix: Electrical Safety The number of physician’s names appearing in the Ordering and Primary Care Physician drop down lists on the General tab of the Enter Patient Information screen. The display language. Changes will take effect when you restart MotiliGI. The unit of measure, English or metric.

  • Page 90: Report Tab

    Appendix: Electrical Safety Show or hide the plot The ranges, tick values and colors of the X and Y axes You can select preferences for Visibility: Show or hide gridlines, annotations, and missing data packets You can select preferences for Color Scheme: The color of gridlines, annotations, title text, and background color Report Tab You can select an option for printing reports.

  • Page 91: Creating Report Letterhead

    Appendix: Electrical Safety Creating Report Letterhead 1. Select Tools > Options > Report Tab. 2. Choose paper size. 3. Click Create Letterhead. The Letterhead Creator appears: Add text to the letterhead 1. Click New Text Box. A text box appears in the new letterhead. 2.

  • Page 92: Files Tab

    Appendix: Electrical Safety To resize the image box drag your mouse to the desired size and click to apply. 6. Click Save. Files Tab You can select the target folder to save files to. Click Browse to find target folder. Type in the folder location.

  • Page 93: Changing The Graph Display

    Appendix: Electrical Safety 1. To access the patient information either: Click on the toolbar Click View > Patient Info. 2. Edit the patient’s information. 3. Click OK. Changing the Graph Display Selecting Data Plots MotiliGI gives you 3 methods to select the data (pressure, pH and temperature) displayed on the graph: Method 1 Context Menu...

  • Page 94: Changing The Test View

    Appendix: Electrical Safety Method 2 Toolbar Icons Click on a “Show/Hide” data plot icon. ► Show/Hide Pressure Show/Hide pH Show/Hide Temperature Method 3 Main Menu Click View > Plots. Select a data plot icon to toggle the plot. ► Changing the Test View To undo any view operation, click the toolbar icon.
  • Page 95 Appendix: Electrical Safety Display Ingestion – Test data around the ingestion marker. Display Stomach – Test data between the ingestion marker and the gastric emptying marker. Display Gastric Emptying – Test data around the gastric emptying marker Display Small/Large Bowel – Test data from the gastric emptying marker to the body exit marker.

  • Page 96: Changing Axis Scales

    Appendix: Electrical Safety Clicking and dragging your mouse to select a graph region (This method zooms in on both the X and Y axis) 3. Click to exit the zoom in mode. The cursor returns to normal. To return to your last view use the icon.

  • Page 97: Analyzing Data

    Appendix: Electrical Safety 3. Click OK. X Axis To change the time format between calendar date/time and elapsed time either: Double-click on the time axis to toggle between elapsed time or real date/time. Go to Tools > Options >Graph > Time Axis Analyzing Data Showing and Hiding Annotations Annotations include patient diary events, range annotations, and point annotations.

  • Page 98: Creating New Event Annotations

    Appendix: Electrical Safety (Optional) You can enter text in the Caption box and in the Notes box. Caption text shows on the graph, while Notes text shows in the Annotation Viewer and in the printed report. You can click the checkboxes to show or hide the annotation and the caption. 4.

  • Page 99: Adding Or Changing The Location Of Physiological Markers

    Appendix: Electrical Safety 1. Click on the toolbar. 2. Move cursor over the caption text. The cursor changes to a crosshair. 3. Click and drag the caption text to a new location. To delete an annotation: 1. Double-click the event icon. The Point Annotation Editor appears. 2.

  • Page 100: Viewing Transit Times

    Appendix: Electrical Safety Viewing Transit Times Click on the toolbar. Select View > Test Summary The Test Summary screen appears. Transit times computed using the physician- defined markers appear on the left and MotiliGI-computed markers appear on the right. Calculating Statistics To enter the Statistics mode: 1.

  • Page 101: Creating Output

    Appendix: Electrical Safety (Optional) You can enter text in the Caption and Notes boxes. You can click the checkboxes to show or hide the annotation and the caption. 2. Click OK. You can create and save multiple range annotations. To exit the Statistics mode, Click on the toolbar.

  • Page 102: Exporting Data To Excel

    Appendix: Electrical Safety Select Action > Generate Report The report opens in Microsoft WordPad. MotiliGI immediately saves the report to the patient’s folder using a default name. Caution Edits made to the WordPad report will not be saved to the MotiliGI test. To save the report: 1.
  • Page 103 Appendix: Electrical Safety 2. Name the folder. 3. Click Save. To Export the Entire Test 1. Select File > Export > Complete Test Data. A Save As screen appears MotiliGI creates a folder that contains separate CSV files for pH, pressure and temperature.

  • Page 104: Exporting Images To Jpeg Or Gif

    Appendix: Electrical Safety Data Set Units pH units Pressure mmHg Temperature °C Calibrated Data is converted data adjusted by the calibration point (pH 6, atmospheric pressure, room temperature). Temperature Compensated is the calibrated data adjusted for sensor drift due to increased temperature.

  • Page 105: System Administrator Tools

    Appendix: Electrical Safety Password Management Logging into the System Computer For security purposes, after 5 unsuccessful attempts to logon, the user will not be allowed to logon for 15 minutes Enter the Windows user name and password noted below. User Name Password Privileges sgims1...

  • Page 106: Logging Into Motiligi

    Appendix: Electrical Safety Logging into MotiliGI When using MotiliGI for the first time, an administrator account is set up. The administrator has privileges to set up additional users and, edit user names and passwords. Forgotten Password If a user has forgotten his or her password, the administrator must log into MotiliGI and reset the user’s password.

  • Page 107: Backing Up Patient Files

    Appendix: Electrical Safety Security enabled is the default setting and requires users to log in with their username and password. Security disabled eliminates the login (user authentication) step. The user will be logged into the default user account. Recommendation: Assign a unique username and password to each MotiliGI user. The username is used as the Technician Name in the printed report.

  • Page 108: Installing Software

    Appendix: Electrical Safety Confirm the files have been saved by opening the Removable Disk (E:) in Windows Explorer. Click located on the right side of the Start bar. Select Safely remove the Removable Disk (E:). Installing Software To install third-party software, log into the system computer as the system computer administrator –...

  • Page 109: Installing Software From A Cd

    Appendix: Electrical Safety Figure 15 Installing Software from a CD 1. Place the CD in the CD-ROM drive and click Update from CD. The contents of the CD will be displayed in the center box of the main screen. 2. Double click on the file you wish to install. Installing Software from a File on the System Computer Hard Drive 1.

  • Page 110: Uninstalling Motiligi

    Appendix: Electrical Safety Uninstalling MotiliGI Caution If you find it necessary to uninstall MotiliGI, ensure you have backed up and/or saved patient test files, exported data files and reports (except those that have been saved as PDFs) to another location on your hard drive or to external media (e.g., auxiliary or external hard drive, CD).
  • Page 111 Appendix: Electrical Safety Figure 17 6. Double-click on the MotiliGI folder. 7. Double-click on Setup.exe. Follow all instructions in the installation wizard. 8. When the wizard finishes, close the wizard and close MotiliGI Administrator. 9. Reboot the PC. If you are installing MotiliGI on a computer other than your system computer (for reading test data only), you will need to install Adobe Acrobat Reader 7.0 or greater for MotiliGI to run properly.

  • Page 112: Appendix: Electrical Safety

    – Collateral standard: Electromagnetic compatibility – Requirements and tests. electromagnetic emissions The SmartPill GI Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the SmartPill GI Monitoring System assures that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 113 The SmartPill GI Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the SmartPill GI Monitoring System should assure that it is used in such an environment. Immunity test...
  • Page 114 Guidanc electromagnetic immunity The SmartPill GI Monitoring System is intended for use in the electromagnetic environment specified below. The user of the SmartPill GI Monitoring System should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic environment –...
  • Page 115 Recommended separation distances between portable and mobile RF communications equipment and the SmartPill GI Monitoring System The SmartPill GI Monitoring System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the...

  • Page 116: Index

    Device Classifications SmartPill pH.p Capsule SmartPill Data Receiver SmartPill Docking Station Internally Powered Internally Powered Equipment Class I Equipment Power: Equipment Type BF Applied Part Type BF Applied Part Ordinary Equipment Electric Shock Protection: Watertight Equipment Ordinary Equipment Ordinary Equipment Harmful Ingress Water: (IP57)
  • Page 117 Accessories, 6 Gastroparesis, 9 Activation Fixture, 5 GET. See Gastric emptying time Adverse Events, 13 Graph Display, 96 Body Exit, 63, 82 ICJ. See Ileo-Cecal Junction Capsule Ileo-Cecal Junction, 60, Activation, 32 Ingestion, 80 Confirming Exit, 45 Installing Software, 112 Deactivating, 41 Intended Use/Indications for Use, 9 Low Voltage, 62...
  • Page 118 Date, Time, Language and Regional Analyzing, 49 Options, 17 Downloading, 43 Logging in, 109 Test Analysis Wizard, 47 Power Requirements, 10 Test Initiation Wizard, 27 Requirements, 6 Test Summary Reports, 76 Set up, 17 Troubleshooting and Support, 15 Templates User Preferences, 90 Creating, 30 WGTT.

  • Page 119: Contacting Given Imaging

    Given Imaging (Asia) Company Limited 27/F. Unit A, Cheuk Nang Plaza Canada 250 Hennessy Road, Wanchai Given Imaging, Inc. - Canadian Office Hong Kong 2425 Matheson Blvd. E., 8th Floor Phone: +852 2989 0888 Mississauga, ON L4W 5K4 Fax: +852 2989 0899 Canada supportAP@givenimaging.com...
  • Page 120 This manual and the compilation of the content in this manual, including but not limited to text, graphics, logos and images, is the exclusive property of Given Imaging and is protected by United States and international copyright laws. This manual may not be transferred in any form without permission of Given Imaging.

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